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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE
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TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE Back to Search Results
Catalog Number AE05ML
Device Problems Leak/Splash (1354); Difficult to Open or Close (2921)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device history review for the product auto endo5 ml lot# 73l1800543 investigation did not show issues related to the complaint.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that during a laparoscopy-assisted distal gastrectomy, the second or third clip was loaded misaligned and the jaws did not open.The user replaced the device with a new one and the same issue occurred.Therefore, the user stopped using applier and opened a competitor's device to continue the operation.No clips fell in the patient.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one unit ae05ml autoend05 ml for investigation.Two loose clips that were closed were also returned.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was returned with its trigger partially engaged and with the rotation tab bent.The returned sample appears used as there is biological material present on the device.First, the trigger cycle was completed.Functional inspection was then performed on the returned sample by attempting to engage the trigger using hand pressure.Upon engagement of the trigger, an audible ratchet sound could be heard indicating that the internal ratchet ears are intact.The next clip was unable to load properly as it became stuck in the bent rotation tab.The sample was disassembled to inspect the internal components.The proximal end of the feeder was found bent.The sample was received with 2 clips remaining in the channel, indicating that 13 clips were fired by the end user including the two loose clips returned closed.The bent rotation tab, the clip being stuck in the bent rotation tab and the proximal end of the feeder being bent are indications that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.The ifu for this product, l06072, was reviewed as a part of this complaint investigation.The ifu for this product states, "mishandling of appliers may result in improper load and/or closure of the ligating clip." the clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.The reported complaint of "clips loaded misaligned" was confirmed based upon the sample received.One device was returned with its trigger partially engaged and with the rotation tab bent.Upon functional inspection, the next clip was unable to load properly as it became stuck in the bent rotation tab.The sample was disassembled to inspect the internal components.The proximal end of the feeder was found bent.The sample was received with 2 clips remaining in the channel, indicating that 13 clips were fired by the end user including the two loose clips returned closed.The bent rotation tab, the clip being stuck in the bent rotation tab and the proximal end of the feeder being bent are indications that the clips were out of position and stacking on one another.The clip stacking could prevent the clips from loading properly into the jaws.It could not be determined exactly how or when the clips came out of position.A non-conformance has been opened to further investigate this issue.
 
Event Description
It was reported that during a laparoscopy-assisted distal gastrectomy, the second or third clip was loaded misaligned and the jaws did not open.The user replaced the device with a new one and the same issue occurred.Therefore, the user stopped using applier and opened a competitor's device to continue the operation.No clips fell in the patient.
 
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Brand Name
AUTO ENDO5 ML
Type of Device
CLIP, IMPLANTABLE
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8544269
MDR Text Key142908481
Report Number3003898360-2019-00464
Device Sequence Number1
Product Code FZP
Combination Product (y/n)N
PMA/PMN Number
K152081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/18/2021
Device Catalogue NumberAE05ML
Device Lot Number73L1800543
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2019
Initial Date Manufacturer Received 04/08/2019
Initial Date FDA Received04/24/2019
Supplement Dates Manufacturer Received05/23/2019
Supplement Dates FDA Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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